MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Sensing Problem (2917)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/01/2016

Event Type  Injury  

Event Description

It was reported on (b)(6) 2016 from a physician that the patient recently had a pacemaker implanted.The physician was calling to see what effect a pacemaker could have on the vns device.He was informed that the pacemaker is unlikely to have any effect on the vns.He was told that the pace maker could potentially sense the stimulation delivered by vns.The physician then reported that the patient is having some cardiac issues.He stated that he wanted the device to be programmed off to rule out the vns as the cause for the cardiac issues.The patient does not have a following physician for the vns.On (b)(6) 2016 it was stated that the patient was discharged that day and they are not sure what was making the patient hypotensive.Attempts have been made to the patient's last known neurologist but no relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5564271
• MDR Text Key: 42376476
• Report Number: 1644487-2016-00750
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2011
• Device Model Number: 103
• Device Lot Number: 201130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR